Just when you thought it was safe to go back into the ocean, someone spots another shark. As noted in our post yesterday (here), the Office of Generic Drugs (OGD) fully approved 63 ANDAs and tentatively approved 16 ANDAs in March. We were hoping to see approval actions outpace receipts, however, much to our surprise, OGD received 115 ANDAs in March 2016 (as the theme of Jaws plays in the background).
The balance we thought was occurring between ANDA receipts and approvals seems to have shifted back to be more lopsided towards receipts. In the first 6 months of this fiscal year, OGD has received 473 ANDAs, which will translate into about 946 applications for FY 2016, if the current trend continues. Looking at the number of full approvals projected for FY 2016, if current approval rates continue, we anticipate about 692 ANDA approvals. That means that receipts will outpace approvals by about 250 applications. Remember, FY 2015 saw the lowest number of post-GDUFA original ANDA receipts at 539, which gave OGD a bit of a reprieve, as OGD projected a flat yearly number of receipts at about 750 during the initial GDUFA negotiations. That dip in receipts appears to be over (at least for this FY) as the number of receipts looks like it will push up against the 1000 mark that has been the rule, rather than the exception, since the implementation of GDUFA.
While the FY 2016 numbers will put more pressure on OGD and Office of Product Quality (OPQ) reviewers, OGD is maintaining that it will continue to meet all GDUFA goals. Let’s hope that that is the case.